The present invention relates to weight control and, more particularly, to a system and method to inhibit gastric expansion.
Obesity in adults and children has been dramatically increasing in the United States and abroad. Of particular interest is morbid obesity. Obesity typically is determined based on a body mass index (BMI), which is a ratio of weight and height. In general, a BMI of 30 or greater is considered obese and a BMI of 40 or greater is considered morbidly obese.
Obesity can be associated with several detrimental physiological conditions. For example, obesity often makes it difficult to breathe (e.g., sleep apnea) and may cause severe shortness of breath. Obese women may further have irregular menstruation patterns. More serious conditions, such as gallbladder disease, hypertension, diabetes, and high blood pressure, also may accompany obesity. Physical conditions also may develop as a result of obesity, such as osteo-arthritis at various joints that are subject to increased stress due to the obese condition. An Obese person also may suffer from various social and psychological effects due to their condition.
In an effort to reduce the occurrence of obesity, several surgical procedures have been developed in situations when dieting alone is inadequate. One type of procedure, commonly called gastric banding, is implemented by placing a band around the stomach to restrict its expansion and thereby reduce the consumption of food. In order to provide a means to adjust the diameter of the banding, a band was developed having an inflatable balloon on the inside thereof, similar to a blood pressure cuff. The balloon could be connected to an injection port, which could be used to adjust inside diameter of the band postoperatively. As a result, the restriction around the stomach could be modified according to the needs of an individual patient.
However, such gastric banding techniques have not been completely satisfactory. For example, conventional bands have a tendency to dislocate and travel downwards towards the lower part of the stomach. In addition, it has been determined that the upper part of the stomach above the band tends to rapidly increase in size. For example, an upper gastric pouch formed by the banding may increase up to ten times its original volume, facilitating increased food consumption and less weight reduction.
Another more invasive surgical method is gastric bypass in which the stomach is stapled vertically to create a small vertically oriented pouch for food intake. A lower part of the stomach and a varying amount of the small intestine is bypassed. Gastric bypass is usually a permanent procedure and can lead to serious complications, such as anemia, poor nutrient absorption. In addition, there is an increased difficulty to evaluate the gastrointestinal tract, as a substantial portion of it is blocked by staples. A dumping syndrome also may occur with gastric bypass, which may include symptoms of flushing, abdominal pain, and diarrhea after rapid emptying of food into the jejunum.
Vertical banded gastroplasty (VBG) is an alternative to gastric bypass in which a surgeon makes a circular window through the stomach a few inches below the esophagus. Stapling from the window to the esophagus creates a small vertical pouch. A band of polypropylene is inserted through the window and around the outlet of the pouch and sutured to itself to form a closed band loop. While VBG mitigates the complications cause by bypassing the stomach and part of the small intestine, other problems still exist. For example, there is an increased risk of re-operation due to the patient tearing the suture line. In addition, the patient""s stomach pouch may become obstructed unless food is chewed sufficiently and large pills are crushed prior to consumption.
While such surgical procedures may initially reduce the size of the stomach and, thereby reduce consumption, such procedures are not without risks and complications, as noted above.
The following presents a simplified summary of the invention in order to provide a basic understanding of some aspects of the invention. This summary is not an extensive overview of the invention. It is intended to neither identify key or critical elements of the invention nor delineate the scope of the invention. Its sole purpose is to present some concepts of the invention in a simplified form as a prelude to the more detailed description that is presented later.
One aspect of the present invention provides a system and method to inhibit radial expansion the stomach. The system includes an elongated band (or patch) of a flexible biocompatible material. In accordance with a particular aspect, the material may be formed of a natural tissue material, such as animal pericardium that has been fixed in a suitable fixation solution. The band has a central body portion and elongated end portions extending longitudinally from opposed ends of the body portion. The end portions have a width that is less than the body portion.
A slot is formed through an intermediate portion of the body portion. The slot is adapted to receive one of the end portions there through. In particular, part of the central body portion located intermediate the slot and one of the end portions has a width that approximates or is slightly less than the length of the slot. Accordingly, the banding system may be wrapped around a desired part of an organ (e.g., the stomach) and an end portion may be inserted through the slot and the two opposed end portions urged apart to form a cylindrical body member of the central body portion having a desired diameter. Next, the end portions may be tied off (or otherwise secured) so that the cylindrical member maintains at least the desired diameter.
In accordance with another aspect of the present invention, a wrapping system may be used in conjunction with a banding apparatus to further limit dilation of part of an organ, such as the stomach. The wrapping system includes a sheet of a flexible biocompatible material dimensioned and configured to have a sufficient surface area to wrap around the part of the organ. A plurality of slots or apertures extend through the sheet at spaced apart locations in a substantial portion of the sheet. The slots or apertures operate to permit a limited amount of expansion of the sheet. In accordance with a particular aspect of the present invention, the sheet is formed of a biocompatible natural tissue material, such as, for example, treated animal pericardium.
To utilize the wrapping system in combination with a banding apparatus, the wrapping system is applied circumferentially around the desired part of the organ with one end being positioned adjacent the banding system. In order to selectively limit the amount of expansion of the organ, an inflatable balloon or bladder may be inserted within the organ and inflated to approximate a desired maximum volume thereof. Then, by applying the sheet about the inflated organ in a substantially tight condition, and securing the wrapping about the organ, expansion of the organ will be limited to about that volume. The end of the wrapping system may, in turn, be attached to the banding system, so as to inhibit axial movement of the applied banding system relative to the organ.
According to another aspect of the present invention, the wrapping system may be employed, with or without the banding, to inhibit diaphragmatic hernia. The wrapping system may be applied around a portion of the stomach adjacent the esophagus with one end of the wrapping system being applied so as to circumscribe the esophagus. A distal portion of the wrapping system in turn is applied around the stomach and sutured together to form a cylindrical around at least part of the stomach. An anchor of a biocompatible material is attached to the wrapping system and to an adjacent internal body part, such as the abdominal wall or the diaphragm at a location distal the esophageal hiatus. As a result, the wrapping system and the upper portion of the stomach within the wrapping system are inhibited from herniating through the esophageal hiatus.